Edwards Lifesciences Sr Clinical Development Specialist THV in Irvine, California
Become a driving force in the launch and development of the groundbreaking, interventional cardiology device, the Transcatheter Heart Valve (THV).
We are looking for a passionate Sr. Clinical Development Specialist to drive new product iterations and product approvals for commercial use in various global geographies, utilizing clinical research, and product design and development processes. This individual will work cross-functionally across project teams to prepare and provide identified clinical deliverables. Ensure successful product lifecycle management for one or two projects, including:
Develop and implement pre-clinical test strategy and provide guidance to team members on strategy execution.
Create Clinical Investigator Brochure.
Provide product expertise for new product introduction training for clinical and site personnel.
Design, develop, conduct, and assess results of post-market evaluations.
Ensure medical and scientific factors are considered during cross-functional product development project team meetings inclusive of literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports.
Consult with field trial managers to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
Provide case support and assistance to physicians during transcatheter implantation procedures.
Act as a Document Management system (e.g., Ignite) expert to team for troubleshooting, ensuring proper procedures are followed and resolving issues for documents in clinical product development.
Create and present customized technical and clinical content to educate and employees on clinical matters relating to EW products. When necessary, lead training and provide hands-on coaching and mentorship in the field for new EW products.
Provide support and troubleshoot for document initiation to Clinical Affairs team.
M inimum Requirements:
Bachelor's degree in engineering degree required.
Five years’ experience in Class II and III medical device technologies and or clinical studies background required.
Interventional cardiology experience, TAVR experience highly preferred.
Experience with documentation management systems (e.g., Ignite) preferred.
Experience with benefit risk assessments and usability studies is preferred.
Additional Talents and General Expectations:
Good understanding policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies.
Good understanding of pre-clinical testing protocols, hospital environments and sterile techniques.
Good knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata).
Good written and verbal communications skills interpersonal relationship skills.
Ability to manage competing priorities in a fast-paced environment.
Works independently on arranging own activities in accomplishing objectives.
Develops solutions to a variety of problems of basic scope and complexity.
Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery.
Ability to travel up to 20%
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.